Not specified (potentially hybrid or remote based on location).
Aggregate report authoring and review
Signal management and detection activities
Regulatory agency response documentation
IQVIA UK is seeking a Pharmacovigilance Scientist (Safety Aggregate Report Specialist) to join their expanding Lifecycle Safety Medical team in various countries, including Serbia, Croatia, and South Africa. The role involves authoring and reviewing aggregate safety reports, managing signals, and ensuring compliance with regulatory standards
Job Summary
The role serves as the principal owner for Safety Aggregate Report deliverables ensuring compliance with all applicable service level agreements.
Candidates will lead the authoring and finalization of critical aggregate reports including PBRERs, PSURs, and DSURs while managing signal detection activities.
This position requires acting as a literature lead to identify ICSRs from literature and contribute to ongoing safety surveillance for marketed and investigational products.
Matching Summary
Match Score: 75
IQVIA UK is seeking a Pharmacovigilance Scientist (Safety Aggregate Report Specialist) to join their expanding Lifecycle Safety Medical team in various countries, including Serbia, Croatia, and South Africa. The role involves authoring and reviewing aggregate safety reports, managing signals, and ensuring compliance with regulatory standards.
Skills & Requirements
Must-have
Aggregate report authoring and review
Signal management and detection activities
Regulatory agency response documentation
Literature safety surveillance execution
PBRERs, PSURs, DSURs, PADERs preparation
Nice-to-have
Mentorship of less experienced resources
Cross-functional team collaboration skills
Adaptability to new service lines
Strong organizational and time management
Proactive risk characterization abilities
Key Requirements
Bachelor's Degree in Scientific or Healthcare discipline
1-2 years prior experience in drug safety or aggregate reporting
Knowledge of Standard Operating Procedures (SOPs) and medical terminology